Identity
- Trade Name
- CONTEC FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- Automatic Biochemistry Analyzer FDA UDI
- Model / Reference
- BC3000 FDA UDI
- Description
- Automatic Biochemistry Analyzer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945040104667 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple clinical chemistry analyser IVD, laboratory
Contec by Contec Medical Systems Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry analyser IVD, laboratory.
- ZELLECHEM-PRO — STERILE SAFEQUIP & CHEMICALS LLP · Class I
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class I
- ABX PENTRA 400 ISE — Horiba Abx · Class I
- IDS-iSYS Cuvettes — IMMUNODIAGNOSTIC SYSTEMS FRANCE · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- DYNEX DSX — DYNEX TECHNOLOGIES, INC. · Class I
- ABS800 Chemistry Analyzer — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
Sources (1)
- FDA UDI b87cc8b1-a358-490c-9fe7-ec5ac84aeb0e 33 fields · synced Jun 7, 2026